bumetanide

Individualize dosage with careful monitoring of patient response. Oral Administration The usual total daily dosage of bumetanide tablets USP is 0.5 mg to 2 mg and in most patients is given as a single dose. If the diuretic response to an initial dose of bumetanide tablets USP is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5-hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby bumetanide tablets USP are given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, keep the dosage to a minimum. Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide in proportion to furosemide in patients allergic to furosemide. Parenteral Administration Bumetanide injection may be administered parenterally (intravenously and intramuscularly) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical. Terminate parenteral treatment and institute oral treatment as soon as possible.

The most frequent clinical adverse reactions considered probably or possibly related to bumetanide tablets are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with pre-existing liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with bumetanide tablets. Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with bumetanide use. Less frequent clinical adverse reactions to bumetanide tablets are impaired hearing (0.5%), pruritus (0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal pain (0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%) and vomiting (0.2%). One or more of these adverse reactions have been reported in approximately 2.9% of patients treated with bumetanide tablets. Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients, are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dry mouth, upset stomach, renal failure, asterixis, itching, nipple tenderness, diarrhea, premature ejaculation and difficulty maintaining an erection. Laboratory abnormalities reported have included hyperuricemia (in 18.4% of patients…

Bumetanide tablets are contraindicated in anuria. Although bumetanide tablets can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide tablets. Bumetanide tablets are also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide tablets are contraindicated in patients hypersensitive to this drug.

Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Drugs with Ototoxic Potential (see WARNINGS) Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions. Drugs with Nephrotoxic Potential There has been no experience with the concurrent use of bumetanide tablets with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided. Lithium Lithium should generally not be given with diuretics (such as bumetanide tablets) because they reduce its renal clearance and add a high risk of lithium toxicity. Probenecid Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide tablets. This antagonistic effect of probenecid on bumetanide tablets natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with bumetanide tablets. Indomethacin Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide tablets treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with bumetanide tablets are thus not recommended. Antihypertensives Bumetanide tablets may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs. Digoxin Interaction studies in humans have shown no effect on digoxin blood levels. Anticoagulants Interaction studies in humans have shown bumetanide tablets to have no effect on warfarin metabolism or on plasma prothrombin activity.